MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-09-11 for RADIAL JAW PULMONARY 3 * 1523 manufactured by Boston Scientific Corp.
[22118019]
The complaint is confirmed. Based on investigation, the complaint sample returned does not close properly due to pull wire broken. However, there is not enough evidence to determine the cause of failure of the device. Our directions for use outline appropriate placement, access and maintenance procedures.
Patient Sequence No: 1, Text Type: N, H10
[22183759]
The complainant reported that the radial forcep would not close and could not be put through the scope during preparation. No pt complications due to the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000150-2006-00002 |
| MDR Report Key | 882285 |
| Report Source | 05,06,07 |
| Date Received | 2006-09-11 |
| Date of Report | 2006-06-30 |
| Date Mfgr Received | 2006-07-14 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2007-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEN HIRAKAWA |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086836264 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORP |
| Manufacturer Street | 302 PARKWAY GLOBAL PARK |
| Manufacturer City | HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIAL JAW PULMONARY 3 |
| Generic Name | BIOPSY FORCEPS |
| Product Code | DWZ |
| Date Received | 2006-09-11 |
| Returned To Mfg | 2006-07-14 |
| Model Number | * |
| Catalog Number | 1523 |
| Lot Number | 559434 |
| ID Number | * |
| Device Expiration Date | 2008-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 861012 |
| Manufacturer | BOSTON SCIENTIFIC CORP |
| Manufacturer Address | 302 PARKWAY GLOBAL PARK HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-11 |